Data / Medical devices / United States / Unboxed Inc.
Unboxed Inc.: FDA-registered device maker in San Jose, CA, United States, 5 510(k) clearances
Unboxed Inc. is registered with the FDA (registration 3038641388) in San Jose, CA, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038641388
- Address
- 5799 Fontanoso Way, San Jose, CA, United States, 95138
- Owner or operator
- Unboxed Inc. (10094703)
- Roles
- Complaint file establishment
- First device listed
- December 17, 2025
- Registered through
- 2026
- Brand names listed
- Banana Gold, Intimina, KEGEL SMART, KEGELSMART PEARL, LELO RESPECT HEX Natural Rubber Latex Condom, LELO Smart Wand, Lelo Hex Lubricated Natural Rubber Latex Condom, Lelo Hex Natural Rubber Latex Condom
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Complaint file establishment | accessdata.fda.gov |
| Cup, Menstrual | HHE | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
| Perineometer | HIR | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 7, 2025 | K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | HIS | Substantially Equivalent | Lelo, Inc. | accessdata.fda.gov |
| January 13, 2017 | K162511 | LELO RESPECT HEX Natural Rubber Latex Condom | HIS | Substantially Equivalent | Lelo, Inc. | accessdata.fda.gov |
| June 30, 2016 | K160644 | Lelo Hex Natural Rubber Latex Condom | HIS | Substantially Equivalent | Lelo, Inc. | accessdata.fda.gov |
| August 14, 2015 | K150857 | Banana Gold | HIS | Substantially Equivalent | Hankook Latex Gongup Co., Ltd. | accessdata.fda.gov |
| September 10, 2014 | K140780 | KEGEL SMART, KEGELSMART PEARL | HIR | Substantially Equivalent | Regulatory Insight, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Perineometer
- All makers of Condom
- All makers of Massager, Therapeutic, Electric
- All makers of Cup, Menstrual
Updated March 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.